Percutaneous transcatheter repair of heart valves

ABSTRACT

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the outer hollow member. The internal anchor member includes a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. The internal anchor member is configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/370,754, filed Aug. 4, 2010, andtitled “PERCUTANEOUS DELIVERY OF ANNULOPLASTY RINGS TO HEART VALVES,” ofU.S. Provisional Patent Application No. 61/383,681, filed Sep. 16, 2010,and titled “PERCUTANEOUS DELIVERY OF ANNULOPLASTY RINGS TO HEARTVALVES,” and of U.S. Provisional Patent Application No. 61/492,279,filed Jun. 1, 2011, and titled “TRANSCATHETER FIXATION OF ANNULOPLASTYRINGS,” each of which is hereby incorporated herein by reference in itsentirety.

TECHNICAL FIELD

The present disclosure relates to treating and repairing heart valves,and specifically to apparatus, systems, and methods for percutaneoustranscatheter delivery and fixation of annuloplasty rings to repairheart valves. Disclosed ring embodiments are configured to be deliveredthrough a catheter using, for example, a trans-septal approach, aretrograde approach, or a trans-apical approach.

BACKGROUND INFORMATION

Heart valve defects, such as regurgitation, may be caused by arelaxation of the tissue surrounding a heart valve (e.g., the mitralvalve or tricuspid valve). This causes the valve opening to enlarge,which prevents the valve from sealing properly. Such heart conditionsare commonly treated by a procedure during which an annuloplasty ring isfixed or secured around the valve. Cinching or securing the tissue tothe ring can restore the valve opening to its approximate original sizeand operating efficiency.

Typically, annuloplasty rings have been implanted during open heartsurgery, so that the annuloplasty ring can be sewn into the valveannulus. Open heart surgery is a highly invasive procedure that requiresconnecting a heart and lung machine (to pump the patient's blood andbreathe for the patient), stopping the patient's heart, and cutting openthe thoracic cavity and heart organ. The procedure can expose thepatient to high risk of infection and may result in a long and difficultrecovery. The recovery can be particularly difficult for patients inless than optimal health due to the effects of suffering from a heartvalve defect such as regurgitation.

SUMMARY OF THE DISCLOSURE

Disclosed herein are apparatus, systems, and methods for repairing heartvalves through percutaneous transcatheter delivery and fixation ofannuloplasty rings to heart valves.

In one embodiment, an annuloplasty ring includes an outer hollow memberincluding a plurality of segments. Adjacent segments cooperate with oneanother to change the outer hollow member from an elongate insertiongeometry to an annular operable geometry. The annuloplasty ring alsoincludes an internal anchor member located at least partially within theouter hollow member. The internal anchor member includes a plurality ofanchors configured to attach the annuloplasty ring to tissue of a heartvalve annulus. The internal anchor member is configured to move theplurality of anchors with respect to a plurality of windows in the outerhollow member to selectively deploy the plurality of anchors through therespective windows.

In certain embodiments, methods are disclosed for percutaneoustranscatheter repair of a heart valve using the segmented annuloplastyring.

In addition, or in other embodiments, a delivery system is disclosed forpercutaneous transcatheter delivery of the segmented annuloplasty ring.

BRIEF DESCRIPTION OF THE DRAWINGS

Understanding that drawings depict only certain embodiments and are nottherefore to be considered to be limiting in nature, non-limiting andnon-exhaustive embodiments of the disclosure are described and explainedwith additional specificity and detail through the use of theaccompanying drawings.

FIG. 1 is a simplified schematic diagram illustrating a perspective viewof a segmented annuloplasty ring according to one embodiment.

FIGS. 1A and 1B are schematic diagrams illustrating a shape memoryhypotube cut to form a plurality of segments for use as an outer tube ofa segmented annuloplasty ring according to one embodiment.

FIG. 1C is a schematic diagram illustrating a cutting pattern used forlaser processing the hypotube shown in FIGS. 1A and 1B.

FIG. 1D is a schematic diagram illustrating the shape memory hypotubeshown in FIGS. 1A and 1B in an annular (D-shaped) operable geometry.

FIG. 2A is a simplified schematic diagram illustrating a side view of aninternal anchor ribbon including the curved anchors shown in FIG. 1according to one embodiment.

FIG. 2B is a schematic diagram illustrating a top view of the anchorscut into the internal anchor ribbon shown in FIG. 2A in the elongateinsertion geometry according to one embodiment.

FIG. 2C is a schematic diagram illustrating a side view of the internalanchor ribbon in the elongate insertion geometry and the anchors in acurled or curved deployed configuration according to one embodiment.

FIG. 2D is a schematic diagram illustrating a top view of an internalglide ribbon shown in FIG. 2A in an elongate insertion geometryaccording to one embodiment.

FIG. 2E is a schematic diagram illustrating a side view of the internalglide ribbon shown in FIG. 2D.

FIGS. 3A and 3B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring before (FIG. 3A) and after (FIG. 3B)deployment of the anchors shown in FIG. 2C according to one embodiment.

FIG. 4A is a schematic diagram illustrating a perspective view of aportion of the annuloplasty ring shown in FIGS. 3A and 3B with adeployed curved anchor according to one embodiment.

FIG. 4B is a schematic diagram illustrating a side view of a portion ofthe annuloplasty ring shown in FIG. 4A.

FIG. 5 is a simplified schematic diagram illustrating a side view of theinternal glide ribbon shown in FIG. 2A used as a selectively adjustablemember according to one embodiment.

FIGS. 5A, 5B, and 5C are schematic diagrams of circuitry for using RFinduction to activate the shape memory material of the internal glideribbon according to one embodiment.

FIG. 6A is a schematic diagram illustrating a perspective view of asegmented annuloplasty ring including a plurality of linear anchorsaccording to one embodiment.

FIG. 6B is a schematic diagram illustrating a side view of a portion ofthe annuloplasty ring shown in FIG. 6A.

FIG. 7 is a simplified schematic diagram illustrating a side view of aninternal anchor member including linear anchors according to oneembodiment.

FIG. 8A is a schematic diagram illustrating an enlarged perspective viewof a single-barbed anchor of a percutaneous transcatheter annuloplastyring in an affixation configuration according to one embodiment.

FIG. 8B is a schematic diagram of an enlarged perspective view of adual-barbed anchor of a percutaneous transcatheter annuloplasty ring inan affixation configuration according to one embodiment.

FIG. 9 is a simplified schematic diagram illustrating a side view of theinternal anchor member shown in FIG. 7 and a selectively adjustablemember according to one embodiment.

FIG. 10 is a schematic diagram illustrating a partial cross-sectionalview of the selectively adjustable member shown in FIG. 9 according toone embodiment.

FIG. 11A is a schematic diagram illustrating a trans-septal approach forendovascular delivery of an annuloplasty ring to the mitral valve of aheart according to one embodiment.

FIG. 11B is a schematic diagram illustrating an example retrogradeapproach of an annuloplasty ring to the mitral valve of a heartaccording to another embodiment.

FIG. 11C is a schematic diagram illustrating an example trans-apicalapproach of an annuloplasty ring to the mitral valve of a heartaccording to another embodiment.

FIGS. 12A and 12B are schematic diagrams illustrating a delivery systemfor implanting a segmented annuloplasty ring within a heart according tocertain embodiments.

FIGS. 13A, 13B, 13C, 13D, 13E, 13F, and 13G are schematic diagramsillustrating the front of the delivery system shown in FIG. 12Aaccording to certain embodiments.

FIGS. 14A, 14B, 14C, 14D, 14E, 14F, and 14G are schematic diagramsillustrating perspective, partially cross-section views of a heartduring the introduction and affixation of a segmented annuloplasty ringto the annulus of the mitral valve according to certain embodiments.

FIG. 15 is a schematic diagram illustrating a perspective, partiallycross-section view of the heart during the introduction and affixationof the segmented annuloplasty ring using an expandable cage or basket,instead of the balloon shown in FIG. 14F, according to one embodiment.

FIG. 16A is a flowchart of a method for repairing a defective heartvalve according to one embodiment.

FIG. 16B is a flowchart of a method for repairing a defective heartvalve according to another embodiment.

FIG. 17 is a schematic diagram illustrating a perspective, partiallycross-section view of the heart during the introduction and affixationof a segmented annuloplasty ring according to another embodiment.

FIG. 18 is a schematic diagram of a percutaneous transcatheterannuloplasty ring in an annular operable geometry according to oneembodiment.

FIG. 19A is a schematic diagram illustrating the percutaneoustranscatheter annuloplasty ring of FIG. 18 in an insertion geometryaccording to one embodiment.

FIG. 19B is a schematic diagram of the percutaneous transcatheterannuloplasty ring transitioning from the insertion geometry shown inFIG. 19A to the operable geometry shown in FIG. 18 according to oneembodiment.

FIG. 20A is a schematic diagram illustrating a percutaneoustranscatheter annuloplasty ring according to another embodiment.

FIG. 20B is a schematic diagram illustrating an enlarged side view ofthe annuloplasty ring of FIG. 20A according to one embodiment.

FIG. 20C is a schematic diagram of the annuloplasty ring of FIG. 20Awith the anchors in an affixation configuration protruding away from theannuloplasty ring according to one embodiment.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

While there are flexible rings currently on the market, surgeonsgenerally prefer rigid and semi-rigid rings for valve repair to treatischemic and functional mitral valve regurgitation. Rigid and semi-rigidrings, unfortunately, do not lend themselves to being delivered into theheart through a catheter. The present disclosure provides systems andmethods for repairing heart valves through percutaneous transcatheterdelivery and fixation of annuloplasty rings to heart valves. Theembodiments of annuloplasty rings can be configured in both an elongateinsertion geometry that can be inserted into a catheter tube and anoperable geometry providing a curved and rigid or semi-rigid annularshape.

In certain embodiments, an annuloplasty ring is delivered percutaneouslyto the mitral and/or tricuspid valve annulus of the heart. The disclosedembodiments apply, for example, to trans-septal, retrograde, ortrans-apical approaches for delivering annuloplasty rings to an annulusof a heart valve. For delivery of rings into the mitral valve,percutaneous delivery may use a retrograde approach from the femoralartery, an antegrade approach via a trans-septal entry, or atrans-apical approach through the base or apex of the heart through theleft ventricle to the left atrium. Delivery of rings to the tricuspidvalve may include an approach from the inferior or superior vena cava.

Certain annuloplasty rings disclosed herein are small and flexibleenough to be percutaneously delivered, but can be put into a rigid orsemi-rigid ring shape and then securely anchored into the heart valveannulus without having to open up the chest. Disclosed embodimentsinclude segmented annuloplasty rings, delivery systems, and methods foranchoring and cinching the annuloplasty ring around the valve annulus.

Example Ring Embodiments with Curved Anchors

FIG. 1 is a simplified schematic diagram illustrating a perspective viewof a segmented annuloplasty ring 100 according to one embodiment. Thesegmented annuloplasty ring 100 includes a plurality of segments 102, aplurality of anchors 104, a ring closure lock 106, and a pivot 108. InFIG. 1, as well as in other embodiments disclosed herein, the pluralityof segments 102 are arranged in a “D-shape” in the operable geometry(e.g., when implanted around the annulus). The D-shaped ring 100 has acertain geometrical ratio that is in conformance with the anatomicalgeometry of the human mitral valve annulus. For example, as discussedbelow with respect to FIG. 1D, the ratio in certain embodiments of theanterior-posterior (A-P) distance to the commissure-commissure (C-C)distance of the ring 100 when implanted is in a range between about 0.60and about 0.70. In one embodiment, the implanted ratio of the A-Pdistance to the C-C distance is about 0.62. Artisans will recognize fromthe disclosure herein, however, that other operable geometries may alsobe used. For example, circular or oval operable geometries may be used.

In addition to the operable geometry, the plurality of segments 102allow the ring 100 to be placed in an elongate insertion geometry suchthat the ring 102 can be inserted through a catheter into the heart. Asdiscussed in detail below, in certain embodiments, the segmentedannuloplasty ring 100 includes a shape memory (e.g., Nitinol) hypotubeinto which the plurality of segments 102 are laser cut. The shape memoryhypotube is heat set to a “memorized” annular shape (e.g., the D-shapedoperable geometry). The shape memory hypotube is superelastic such thatapplying sufficient stress places the plurality of segments 102 into theelongate insertion geometry and releasing the stress allows theplurality of segments 102 to resume the D-shaped operable geometry.

The plurality of anchors 104 are configured to secure the segmentedannuloplasty ring 100 to the annulus of the heart valve. In certainembodiments, the anchors 104 are sufficient such that additionalsuturing of the segmented annuloplasty ring 100 to the valve annulus isnot needed. In FIG. 1, the anchors 104 are curved in the illustrateddeployed configuration. Anchors in other embodiments may include othershapes, such as linear or helical deployed configurations. In certainembodiments, the anchors 104 include a shape memory material (e.g.,Nitinol) that is heat set to a deployed configuration (e.g., linear,helical, or curved configuration shown in FIG. 1). Artisans willrecognize from the disclosure herein that combinations of differentdeployed configurations may also be used.

The anchors 104 are superelastic such that applying sufficient stressplaces the anchors 104 into an introduction configuration and releasingthe stress allows the anchors 104 to resume their respective deployedconfigurations. In certain embodiments, the anchors 104 lay flat againstthe plurality of segments 102 in the introduction configuration duringinsertion of the ring 100 through the catheter. As discussed below, inother embodiments, the anchors 104 are retracted inside the segmentedring 100 in the introduction configuration during insertion of the ring100 through the catheter. In such embodiments, the anchors 104 may beselectively deployed at a desired time (e.g., after the segmented ring100 is properly positioned against the annulus of the heart valve). Incertain embodiments, the superelastic property of the anchors 104 isused to self-propel the anchors 104 into the annulus of the heart valve.

As discussed below, the pivot 108 is used to automatically rotate thesegmented annuloplasty ring 100 after it exits the catheter within theheart to align the plane of the ring 100 (in the annular operablegeometry) with the plane of the heart valve. The ring 100 is pushed fromthe catheter in a direction that is substantially perpendicular to theplane of the heart valve (e.g., parallel to the direction of bloodflow). Upon exiting the catheter, the pivot 108 rotates the ring 100 toallow the ring 100 to be properly positioned against the annulus. In oneembodiment, the anchors 104 are deployed before pressing the ring 100against the valve annulus (e.g., a balloon may be used to drive thedeployed anchors into the tissue). In other embodiments, the ring 100 ispressed against the valve annulus (e.g., using a balloon) beforedeploying the anchors 104 and the act of deploying the anchors 104drives the anchors 104 into the tissue. Fluoroscopy, ultrasound, and/orother imaging techniques may be used to assist in proper positioning ofthe ring 100 against the heart valve annulus.

The ring closure lock 106 is used to secure the two open ends of thesegmented annuloplasty ring 100 to form a closed ring. As shown in FIG.1, in certain embodiments, the ring closure lock 106 includes a femalesnap 110 and a male snap 112. As discussed below, the segmentedannuloplasty ring 100 may be “snap locked” using wires or sutures topull the male snap 112 into the female snap 110. In certain embodiments,a gap (e.g., between about 3 mm and 5 mm) is left between the femalesnap 110 and the male snap 112 after the anchors 104 are deployed withinthe tissue of the valve annulus. Then, the two ends are snapped togetherto provide cinching of the valve annulus. This cinching is similar to atechnique used by surgeons during open heart surgery (e.g., usingsutures) to draw the valve annulus into a smaller or improved shape thatreduces regurgitation of blood back through the valve.

Although not shown in FIG. 1, certain ring embodiments include aselectively adjustable member (discussed below) for changing the sizeand/or shape of the segmented annuloplasty ring 100 postoperatively tocompensate for changes in the size of the heart and/or the treated heartvalve. Also not shown in FIG. 1, certain ring embodiments include acover disposed about the entire circumference of the segmented ring 100,or selected portions thereof. For example, in certain embodiments, thecover is disposed so as to enclose the plurality of segments 102, whileleaving uncovered at least portions of the ring closure lock 106 (topermit snapping the lock together) and the pivot 108 (to allow accessthereto during insertion of the ring 100). The cover may includeopenings aligned with windows (discussed below) in the plurality ofsegments 102 through which the plurality of anchors 104 are deployed. Inother embodiments, the plurality of anchors 104 are configured topuncture through the cover during deployment. The cover may include abiocompatible material such as Dacron®, woven velour, polyurethane,polytetrafluoroethylene (PTFE), heparin-coated fabric, or the like. Inother embodiments, the cover includes a biological material such asbovine or equine pericardium, homograft, patient graft, or cell-seededtissue.

FIGS. 1A and 1B are schematic diagrams illustrating a shape memoryhypotube 113 cut to form a plurality of segments 102 for use as an outertube (also referred to herein as an “outer hollow member”) of asegmented annuloplasty ring according to one embodiment. FIG. 1A is aplan view of a first side of the hypotube 113 in which a plurality ofanchor deployment windows 114 are cut. FIG. 1B is a plan view of asecond side of the hypotube 113 that is opposite the windows 114 shownin FIG. 1A. For illustrative purposes, FIG. 1C is a schematic diagramillustrating a cutting pattern 116 used for laser processing thehypotube 113 shown in FIGS. 1A and 1B. While FIGS. 1A and 1B showrespective (opposite) sides of the hypotube 113, the cutting pattern 116corresponds to the entire hypotube 113 as if the hypotube were cut alongan axis 118 of the surface shown in FIG. 1A and unrolled. Thus, forexample, each window 114 shown in FIG. 1A is shown in FIG. 1C as beingsplit between a first half of the window 114(a) and a second half of thewindow 114(b).

The hypotube 113 includes a through hole 120, 121 at each end (or twoperpendicular through holes at each end according to FIG. 1C) to allowone or more pins (not shown) to couple the male and female components ofthe ring closure lock 106 to respective ends of the hypotube 113. Thehypotube 113 also includes a through hole 122 (the opening 122 shown inFIG. 1A being represented in FIG. 1C as 122(a) and 122(b)) for anotherpin (not shown) for coupling the pivot 108 to the hypotube 113. As shownin FIG. 1C, the hypotube 113 may also include a window 124 (passingvertically through the hypotube 113 with respect to the views shown inFIGS. 1A and 1B) that allows one or more lines or sutures (not shown) toexit the hypotube 113. As discussed below, the sutures are used to snaplock the ring and/or to deploy the anchors 104.

In FIGS. 1A and 1B, the hypotube 113 is shown in the elongate insertiongeometry. FIG. 1D is a schematic diagram illustrating the shape memoryhypotube 113 shown in FIGS. 1A and 1B in an annular (D-shaped) operablegeometry. In FIG. 1D, the ring closure lock 106 and the pivot 108 arealso shown. For reference, the first side shown in FIG. 1A correspondsto the outer circumference of the ring shown in FIG. 1D, and the secondside shown in FIG. 1B corresponds to the inner circumference of the ringshown in FIG. 1D. FIG. 1D shows an anterior-posterior (A-P) directionand a commissure-commissure (C-C) direction, corresponding to theanatomical structure of a human mitral-valve annulus. As discussedabove, in certain embodiments, the implant size of the D-shaped hypotube113 in the operable geometry has ratio of A-P distance to C-C distancein range between about 0.60 to about 0.70. By way of example only, andnot by limitation, the table below provides some example dimensions.

Ring Implant Shape (mm) Size C-C A-P Ratio 28 28.00 17.36 0.62 30 30.0018.60 0.62 32 32.22 19.84 0.62 34 34.00 21.08 0.62 36 36.00 22.32 0.62

The cutting pattern 116 shown in FIG. 1C defines the configuration ofthe plurality of segments 102 and how the segments 102 interact withadjacent segments as the hypotube transitions from the elongateinsertion geometry shown in FIGS. 1A and 1B to the annular operablegeometry shown in FIG. 1C. As shown in FIG. 1B, the hypotube in thisexample embodiment includes a “tongue and groove” pattern wherein atongue 126 of one segment interfaces with a groove 128 of an adjacentsegment as the inner circumference of the ring is formed. The cuttingpattern 116 provides rigidity to the hypotube 113 in the annularoperable geometry, allows the hypotube 113 to easily transition from theelongate insertion geometry to the annular operable geometry, andsubstantially closes gaps between the segments 102 in the annularoperable geometry.

In certain embodiments, deployment of the anchors 104 is accomplishedusing an internal anchor member that is selectively movable within thehollow tube formed by the plurality of segments 102. For example, FIG.2A is a simplified schematic diagram illustrating a side view of aninternal anchor ribbon 200 including the curved anchors 104 shown inFIG. 1 according to one embodiment. The curved anchors 104 may beaffixed (e.g., laser welded) to the internal anchor ribbon 200 ordirectly cut into the internal anchor ribbon 200 (as discussed withrespect to FIGS. 2B and 2C). Like the anchors 104, the internal anchorribbon 104 includes a superelastic shape memory material (e.g., Nitinol)that is heat set to the same memorized annular shape as the plurality ofsegments 102 (shown in FIGS. 1 and 2A as D-shaped).

The internal anchor ribbon 200 may be slid (e.g., using wires or suturesaccessible through the catheter) within the hollow tube formed by theplurality of segments 102 of the ring 100. To reduce friction betweenthe internal anchor ribbon 200 and the plurality of segments 102,certain ring embodiments include an internal glide ribbon 210. Theinternal glide ribbon 210 may includes a low-friction material (e.g., asa coating or covering) such as PTFE or other polymer. In addition, or inother embodiments, the internal glide ribbon 210 includes a superelasticshape memory material (e.g., Nitinol) that is heat set to the samememorized annular shape as the plurality of segments 102 (shown in FIGS.1 and 2A as D-shaped). Thus, certain embodiments include three D-shapedsuperelastic members (the outer tube of segments 102, the internalanchor ribbon 200, and the internal glide ribbon 210), which cooperateto increase the rigidity of the ring 100.

FIG. 2B is a schematic diagram illustrating a top view of the anchors104 cut into the internal anchor ribbon 200 shown in FIG. 2A in theelongate insertion geometry according to one embodiment. In thisexample, a laser is used to cut the anchors 104 along a first side 212,a second side 214 (e.g., in a pointed or tip shape), and a third side216, while leaving a fourth side 218 of the anchor 104 uncut andattached to the internal anchor ribbon 200. After cutting, the anchors104 are heat set to the desired memorized shape for the deployedconfiguration. For example, FIG. 2C is a schematic diagram illustratinga side view of the internal anchor ribbon 200 in the elongate insertiongeometry and the anchors 104 in a curled or curved deployedconfiguration according to one embodiment. The amount of curvature inthe deployed configuration of the anchors 104 may depend on theparticular application. In the example shown in FIG. 2C, the anchors 104fold back on themselves such that the prong or tip 220 points parallelto or away from the internal anchor ribbon 200. FIG. 2D is a schematicdiagram illustrating a top view of the internal glide ribbon 210, andFIG. 2E is a schematic diagram illustrating a side view of the internalglide ribbon 210, in the elongate insertion geometry according to oneembodiment.

FIGS. 3A and 3B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring 300 before (FIG. 3A) and after (FIG.3B) deployment of the anchors 104 shown in FIG. 2C according to oneembodiment. For illustrative purposes, the ring 300 in FIGS. 3A and 3Bis shown in an elongate insertion geometry. Artisans will recognize fromthe disclosure herein, however, that the anchors 104 are generallydeployed when the ring 300 is in the annular operable geometry.

The illustrated ring 300 includes an outer tube 310 (e.g., formed by theplurality of segments 102 shown in FIG. 1) including a plurality ofanchor deployment windows 312. During the manufacturing of the ring 300,and before the ring 300 is loaded into the catheter, the internal anchorribbon 200 and the internal glide ribbon 210 are inserted into the outertube 310 in a position where the anchors 104 are prevented from exitingthrough the windows 312. As shown in FIG. 3A, inserting the internalanchor ribbon 200 into the outer tube 300 prevents the anchors fromassuming their fully curved deployed configuration.

For deploying the anchors 104, the internal anchor ribbon 200 mayinclude (or may be attached to) a hook or loop 314 for engaging a wireor suture 316 that may be pulled by a user through the catheter (e.g.,in the direction of arrow 318 in FIG. 3A) to move the tip of each anchor104 to a corresponding window 312. In certain embodiments, the anchors104 and windows 312 are arranged such that the tip of each anchor 104reaches its respective window 312 at substantially the same time as theother anchor/window pairs. As shown in FIG. 3B, once the tips of theanchors 104 reach the respective windows 312, the superelasticity of theanchors 104 propels the internal anchor ribbon 200 in the oppositedirection (as indicated by arrow 320) as the anchors 104 spring out thewindows 312 (as indicated by arrow 322) to resume their curvedconfigurations, which drives the anchors 104 into surrounding tissue(e.g., the heart valve annulus). Thus, the superelasticity of theanchors 104 allows the anchors 104 to be self-propelled into the tissueadjacent or proximate to the ring 300.

FIG. 4A is a schematic diagram illustrating a perspective view of aportion of the annuloplasty ring 300 shown in FIGS. 3A and 3B with adeployed curved anchor 104 according to one embodiment. FIG. 4B is aschematic diagram illustrating a side view of a portion of theannuloplasty ring shown in FIG. 4A. As shown in FIGS. 4A and 4B, theouter tube 310 may be cut to define segments (such as the plurality ofsegments 102 shown in FIG. 1). The outer tube 310 also includes thewindows 312 (one window shown in FIG. 4A) described above andschematically represented in FIGS. 3A and 3B. As shown in FIG. 4B, incertain embodiments, the deployed anchors 104 form an angle α (e.g.,about 45 degrees) with a plane 410 of the ring 300 to provide theanchors 104 with improved access to the valve annulus when the ring ispositioned against the valve annulus. During anchor deployment, theplane 410 of the ring 300 is substantially parallel to the plane of thevalve annulus.

FIG. 5 is a simplified schematic diagram illustrating a side view of theinternal glide ribbon 210 shown in FIG. 2A used as a selectivelyadjustable member according to one embodiment. As discussed above,certain ring embodiments include a selectively adjustable member forchanging the size and/or shape of the annuloplasty ring 100 (shown inFIG. 1) postoperatively to compensate for changes in the size of theheart and/or the treated heart valve. Thus, FIG. 5 illustrates theinternal glide ribbon 210 in the D-shaped geometry used immediatelyafter implanting the ring, as well as an “activated” geometry or shape210′ (shown as dashed lines) that further reduces the size of the mitralvalve annulus in the (A-P) direction (as indicated by arrows 510). SuchA-P contraction improves the coaptation of the leaflets such that a gapbetween the leaflets sufficiently closes during left ventricularcontraction. In certain embodiments, the activated shape 210′ alsoexpands in the direction of arrows 512 (the C-C direction) to pullleaflet commissures away from each other, which draws the leafletscloser together and further improves their coaptation. However, incertain other embodiments, the ring 100 does not expand in the directionof the arrows 512.

As used herein, “postoperatively” refers to a time after implanting anannuloplasty ring, such as the segmented annuloplasty ring 100 shown inFIG. 1 or other rings described in other embodiments, and closing thebody opening through which the ring 100 was introduced into thepatient's body. For example, the ring 100 may be implanted in a childwhose heart grows as the child gets older. Thus, the size of the ring100 may need to be increased. As another example, the size of anenlarged heart may start to return to its normal size after the ring 100is implanted. Thus, the size of the ring 100 may need to be decreasedpostoperatively to continue to reinforce the heart valve annulus.

Thus, in certain embodiments, the ring 100 includes a selectivelyadjustable member (e.g., the internal glide ribbon 210 shown in FIGS. 2Aand 5) with a shape memory material (e.g., NiTi Alloy-B) that isresponsive to changes in temperature and/or exposure to a magneticfield. The ring 100 is adjusted in vivo by applying an energy source toactivate the selectively adjustable member and cause it to change to amemorized shape. The energy source may include, for example, radiofrequency (RF) energy, x-ray energy, microwave energy, ultrasonic energysuch as focused ultrasound, high intensity focused ultrasound (HIFU)energy, light energy, electric field energy, magnetic field energy,combinations of the foregoing, or the like. For example, one embodimentof electromagnetic radiation that is useful is infrared energy having awavelength in a range between approximately 750 nanometers andapproximately 1600 nanometers. This type of infrared radiation may beproduced efficiently by a solid state diode laser. In certainembodiments, the implanted ring 100 is selectively heated using shortpulses of energy having an on and off period between each cycle. Theenergy pulses provide segmental heating that allows segmental adjustmentof portions of the annuloplasty ring without adjusting the entireimplant.

In certain embodiments, the ring 100 includes an energy absorbingmaterial to increase heating efficiency and localize heating in the areaof the selectively adjustable member. Thus, damage to the surroundingtissue is reduced or minimized. Energy absorbing materials for light orlaser activation energy may include nanoshells, nanospheres and thelike, particularly where infrared laser energy is used to energize thematerial. Such nanoparticles may be made from a dielectric, such assilica, coated with an ultra thin layer of a conductor, such as gold,and be selectively tuned to absorb a particular frequency ofelectromagnetic radiation. In certain such embodiments, thenanoparticles range in size between about 5 nanometers and about 20nanometers and can be suspended in a suitable material or solution, suchas saline solution. Coatings comprising nanotubes or nanoparticles canalso be used to absorb energy from, for example, HIFU, MRI, inductiveheating, or the like.

In other embodiments, thin film deposition or other coating techniquessuch as sputtering, reactive sputtering, metal ion implantation,physical vapor deposition, and chemical deposition can be used to coverportions or all of the selectively adjustable member. Such coatings canbe either solid or microporous. When HIFU energy is used, for example, amicroporous structure traps and directs the HIFU energy toward the shapememory material. The coating improves thermal conduction and heatremoval. In certain embodiments, the coating also enhances radio-opacityof the annuloplasty ring implant. Coating materials can be selected fromvarious groups of biocompatible organic or non-organic, metallic ornon-metallic materials such as Titanium Nitride (TiN), Iridium Oxide(Irox), Carbon, Platinum black, Titanium Carbide (TiC) and othermaterials used for pacemaker electrodes or implantable pacemaker leads.Other materials discussed herein or known in the art can also be used toabsorb energy.

In addition, or in other embodiments, fine conductive wires such asplatinum coated copper, titanium, tantalum, stainless steel, gold, orthe like, are wrapped around the selectively adjustable member (see,e.g., FIG. 10) to allow focused and rapid heating of the selectivelyadjustable member while reducing undesired heating of surrounding ring100 and/or tissues. In certain such embodiments, the electricallyconductive wires are electrically insulated from other components of thering 100, such as the shape memory material used in the plurality ofsegments 102 and/or the plurality of anchors 104.

The energy source for activating the shape memory material of theselectively adjustable member may be surgically applied after the ring100 has been implanted by percutaneously inserting a catheter into thepatient's body and applying the energy through the catheter. Forexample, RF energy, light energy, or thermal energy (e.g., from aheating element using resistance heating) can be transferred to theselectively adjustable member through a catheter positioned on or nearthe selectively adjustable member. Alternatively, thermal energy can beprovided to the shape memory material by injecting a heated fluidthrough a catheter or circulating the heated fluid in a balloon throughthe catheter placed in close proximity to the selectively adjustablemember. As another example, the shape memory material in the selectivelyadjustable member can be coated with a photodynamic absorbing materialthat is activated to heat the selectively adjustable member whenilluminated by light from a laser diode or directed to the coatingthrough fiber optic elements in a catheter. In certain such embodiments,the photodynamic absorbing material includes one or more drugs that arereleased when illuminated by the laser light. In certain embodiments, asubcutaneous electrode or coil couples energy from a dedicatedactivation unit. In certain such embodiments, the subcutaneous electrodeprovides telemetry and power transmission between the system and theannuloplasty ring. The subcutaneous electrode allows more efficientcoupling of energy to the implant with minimum or reduced power loss. Incertain embodiments, the subcutaneous energy is delivered to theselectively adjustable member via inductive coupling.

In other embodiments, the energy source is applied in a non-invasivemanner from outside the patient's body. In certain such embodiments, theexternal energy source is focused to provide directional heating to theshape memory material of the selectively adjustable member so as toreduce or minimize damage to the surrounding tissue. For example, incertain embodiments, a handheld or portable device including anelectrically conductive coil generates an electromagnetic field thatnon-invasively penetrates the patient's body and induces a current inthe selectively adjustable member. The current heats the selectivelyadjustable member and causes the shape memory material therein totransform to a memorized shape. In certain such embodiments, theselectively adjustable member also includes an electrically conductivecoil wrapped around or embedded in the memory shape material. Theexternally generated electromagnetic field induces a current in theselectively adjustable member's coil, causing it to heat and transferthermal energy to the shape memory material therein.

By way of example, FIGS. 5A, 5B, and 5C are schematic diagrams ofcircuitry for using RF induction to activate the shape memory materialof the internal glide ribbon 210 according to one embodiment. FIG. 5Aillustrates circuitry located in a selectively adjustable annuloplastyring and FIG. 5B illustrates circuitry of an external (i.e., external tothe patient) RF induction activation system according to one embodiment.FIG. 5C is a block diagram of a system 520 for inductively activating aselectively adjustable member 522 (e.g., the internal glide ribbon 210)of a ring according to certain embodiments.

Referring to FIGS. 5A, 5B, and 5C, the RF induction activation system520 includes a power source 524 (also referred to herein as an RFgenerator or RFG) capable of creating an alternating electrical signalof suitable power. The power source 524 is connected to a delivery coil526 tuned to resonate at the same frequency as the output of the powersource 524. A capacitor 528 is used to tune the delivery coil 526 toresonate at the desired frequency. The implantable dynamicallyadjustable annuloplasty ring assembly includes a second (receiving) coil530 positioned within the patient that is designed to resonate atsubstantially the same frequency as that of the delivery coil 526connected to the power source 524. A capacitor 532 is used to tune thereceiving coil 530 to resonate at the desired frequency. The receivingcoil 530 is connected to a heating element 534 (represented by aresistance R1 in FIG. 5A) wrapped around the selectively adjustablemember 522 (as shown in FIG. 5C). To activate the annuloplasty ring, thedelivery coil 526 is placed near the receiving coil 530 of theselectively adjustable member 522 (e.g., near the patient's chest) andswitched on. Power from the resonating magnetic field 536 (shown in FIG.5C) is then inductively transferred across the skin barrier to thereceiving coil 530 and converted to electrical current that issubsequently used to heat the selectively adjustable member 522. In anexample embodiment, the inductance frequency is above about 100 kHz sothat any leakage current that may come in contact with the patient wouldnot cause uncomfortable sensations during activation.

In certain embodiments, embedded computing and/or remote temperaturesensing is used. For example, FIG. 5C shows that additional circuitry538 may be implanted in the patient. The additional circuitry 538 mayinclude transmitter circuitry (including an antenna 540), amicroprocessor, power circuitry, and temperature measuring circuitry(e.g., one or more thermocouple (TC) devices 542, coupled to theadditional circuitry 538). Similarly, the RFG 524 may include receivercircuitry 544 (including an antenna 546) for receiving temperature andother data from the additional circuitry 538 implanted in the patient.Although not shown, the RFG 524 may also include a processor forprocessing and displaying the information received from the additionalcircuitry 538 implanted within the patient.

The information received from the additional circuitry 538 may include,for example, the power induced in the selectively adjustable member 522.In one embodiment, the power transferred to the selectively adjustablemember 522 is measured by reading the voltage across the selectivelyadjustable member 522 and/or heating element 534 and, because theresistance of the selectively adjustable member 522 and/or heatingelement 534 is known, the power can be calculated and communicated tothe RFG 524 by the telemetry link. In another example, the temperatureand size of the selectively adjustable member 522 may be sensed and sentby transmitter circuitry in the additional circuitry 538 to thereceiving circuitry 544 via radiotelemetry. Temperature may be sensedusing the thermocouple device 542, and the size of the ring may bededuced via built in strain gauges 548 (e.g., different resistancevalues equal a proportional change in size).

In one embodiment, the RFG 524 automatically finds a resonant point. TheRFG 524 may be programmed to analyze wattage delivered during operation(e.g., as discussed above) and may adjust the output frequency toincrease or maximize the greatest power transfer. This may beaccomplished in certain embodiments by directly monitoring the currentoutput on the delivery coil 526, or the peak voltage induced in thereceiving coil 530 via telemetry.

In one embodiment, the system 520 is capable of multiple resonantfrequencies. For example, the heating element 534 (coupled to theselectively adjustable member 522) may be electrically connected to morethan one coil—each coil having a different natural resonance. In anotherembodiment, different coils may be attached to different heatingelements or devices in the ring that can be operated separately. Thetransmitting power source 524 may have a set of coils (e.g., includingthe delivery coil 526) that can be selectively used to couple to itsrespective sister coil (e.g., including the receiving coil 530) coupledto the selectively adjustable member 522.

By using this wireless technique of power transmission, the patient maybe electrically isolated from the system 520 during activation of animplanted device. Thus, the possibility of electrocution due to a groundfault is eliminated or reduced.

In some embodiments, centering of coils is used. Such embodiments usetechniques of aligning the coils, such as through the use of physicallandmarks molded into a housing of the implanted receiving coil,magnets, and/or infrared lighting. For example, an infrared lightemitting diode (LED) may be installed on the implanted receiving coil530 and may light during activation. An infrared detector located on thedelivery coil 526 may be configured to give a user feedback on how muchlight it receives. A set of magnets may also be strategically placed inthe delivery coil 526 and receiving coil 530. As the magnets are broughtclose together, the magnetic attraction may be utilized to align thecoils 526, 530.

Example Ring Embodiments with Linear Anchors

FIG. 6A is a schematic diagram illustrating a perspective view of asegmented annuloplasty ring 600 including a plurality of linear anchors610 according to one embodiment. Seven linear anchors 610 are shown.However, artisans will understand from the disclosure herein that morelinear anchors 610 or fewer linear anchors may be used. For example,certain embodiments may use ten or more linear anchors 610.

The segmented annuloplasty ring 600 includes a plurality of segments 612at least partially cut into a shape memory hypotube that forms a“D-shape” in the annular operable geometry (e.g., when implanted aroundthe annulus) and may be straightened into an elongate insertion geometryfor implanting the ring 600 within a patient's heart through a catheter.As discussed above with respect to FIG. 1, the ring 600 may also includea ring closure lock 614 (shown in a connected or locked position) forsnap locking the two ends of the ring together, and a pivot 616. In theexample embodiment shown in FIG. 6A, the ring closure lock 614 isconnected directly to the pivot 616 along the straight portion of theD-shaped ring.

As discussed above with respect to other embodiments, the ring 600includes a plurality of anchor deployment windows 618 cut into the shapememory hypotube. The plurality of linear anchors 610 may be selectivelydeployed through the windows 618 in a manner similar to that describedabove for curved anchors 104.

FIG. 6B is a schematic diagram illustrating a side view of a portion ofthe annuloplasty ring shown in FIG. 6A. As shown in FIG. 6B, in certainembodiments, the deployed linear anchors 610 form an angle β (e.g.,about 45 degrees) with a plane 620 of the ring 600 to provide the linearanchors 610 with improved access to the valve annulus when the ring ispositioned against the valve annulus. During anchor deployment, theplane 620 of the ring 600 is substantially parallel to the plane of thevalve annulus. As shown in FIG. 6B, the linear anchors 610 may include apointed prong 621 for penetrating tissue and a barb 622 that secures theanchor to the tissue.

FIG. 7 is a simplified schematic diagram illustrating a side view of aninternal anchor member 700 including linear anchors 710 according to oneembodiment. The linear anchors 710 may be affixed (e.g., laser welded)to the internal anchor member 700. In the embodiment shown in FIG. 7,however, the internal anchor member 700 and linear anchors 710 are cutfrom a single superelastic shape memory (e.g., Nitinol) hypotube. FIG.7, for example, shows remaining tubular portions 712 after the hypotubeis cut to form prongs 714 of the linear anchors 710. The remainingtubular portions 712 facilitate sliding (e.g., using wires or suturesaccessible through the catheter) the internal anchor member 700coaxially within the hollow tube of the ring (e.g., within the segmentedannuloplasty ring 600 shown in FIG. 6).

The internal anchor member 700 is heat set to the same memorized annularshape as the ring. The anchors prongs 714 can be heat set to protrudeoutward through windows cut in the segmented annuloplasty ring 600.Barbs 716 may be laser welded to the prongs 714 to form the linearanchors 710. The linear anchors 710 are retracted/deployed by slidingthe internal anchor member 700 within the segmented annuloplasty ring600.

FIG. 8A is a schematic diagram illustrating an enlarged perspective viewof a single-barbed anchor 808 of a percutaneous transcatheterannuloplasty ring 800 in an affixation configuration according to oneembodiment. The anchor 808 includes a prong 810 and a single barb 812welded to the prong 810. The prong 810 is integrated with or connectedto an inner tube member (not shown, but see FIG. 7) and protrudesthrough a window 820 cut in an outer tube member formed by a pluralityof segments 802.

FIG. 8B is a schematic diagram of an enlarged perspective view of adual-barbed anchor 858 of a percutaneous transcatheter annuloplasty ringin an affixation configuration according to one embodiment. The anchor858 includes a prong 860 and two barbs 862 welded to the prong 860. Theprong 860 is integrated with or connected to an inner tube member (notshown) and protrudes through a window 820 cut in an outer tube memberformed by a plurality of segments 852.

FIG. 9 is a simplified schematic diagram illustrating a side view of theinternal anchor member 700 shown in FIG. 7 and a selectively adjustablemember 900 according to one embodiment. As discussed above, theselectively adjustable member 900 is configured to change the sizeand/or shape of the annuloplasty ring 600 postoperatively to compensatefor changes in the size of the heart and/or the treated heart valve. InFIG. 9, the selectively adjustable member 900 is shown passing throughthe remaining tubular portions 712 of the cut hypotube of the internalanchor member 700. In such embodiments, the selectively adjustablemember 900 may be rod shaped and may have an outer diameter of about 40microns. In other embodiments, the selectively adjustable member 900 maybe located adjacent to the internal anchor member 700 (e.g., around theexternal circumference, the internal circumference, or lateral to theinternal anchor member 700).

The selectively adjustable member 900 includes a shape memory material(e.g., NiTi Alloy-B) that is responsive to changes in temperature and/orexposure to a magnetic field. The selectively adjustable member 900 maybe activated, for example, using any of the energy sources or methodsdescribed above with respect to FIGS. 5, 5A, 5B, and 5C. The activatedgeometry of the selectively adjustable member 900, according to certainembodiments, reduces the size of the mitral valve annulus in the APdirection.

FIG. 10 is a schematic diagram illustrating a partial cross-sectionalview of the selectively adjustable member 900 shown in FIG. 9 accordingto one embodiment. The selectively adjustable member 900 in this exampleincludes a shape memory rod 1010, a heating element 1012 (e.g.,electrically conductive wire) coiled around the shape memory rod 1010,and an electrically insulating cover 1013 surrounding the shape memoryrod 1010 and heating element 1012. The electrically insulating cover1013 prevents current passing through the heating element 1012 fromflowing to nearby metals or other shape memory alloys in the ring (e.g.,the outer segmented annuloplasty ring 600 and/or the internal anchormember 700), or to surrounding tissue. The electrically insulating cover1013 may also provide thermal insulation to protect the surroundingtissue from excessive heat.

As shown in FIG. 10, the selectively adjustable member 900 may includeleads 1014, 1016 for providing induced current through the heatingelement 1012. The leads 1014, 1016 may exit through the septal wall, theright atrium subclavian vein, or both leads may follow the ring contourand exit at P₁/P₂ leaflet junction or P₃/P₂ leaflet junction.

In certain embodiments, the receiving coil 530 (shown in FIGS. 5A and5C) and any associated internal circuitry may be placed anywhere withinthe patient and outside the heart of the patient. For example, thereceiving coil 530 and/or additional circuitry 538 may be implantedimmediately below the surface of the skin and coupled to the heatingelement 1012 (coupled to the selectively adjustable member 900) via oneor more wires extending into the heart. In another embodiment, thereceiving coil 530 and associated internal circuitry may be integratedwith the annuloplasty ring and/or the selectively adjustable member 900.For example, the receiving coil 530 and additional circuitry 538 may beincorporated internal to the annuloplasty ring. In still anotherembodiment, the receiving coil 530 may be implanted adjacent the leadwire and/or the receiving coil, in close proximity to the selectivelyadjustable member 900.

Example Deployment Embodiments

As discussed above, the annuloplasty ring embodiments disclosed hereinare configured for percutaneous transcatheter delivery and fixation toheart valves. The rings may be delivered through a catheter to themitral valve, for example, using a trans-septal approach, a retrogradeapproach, or a trans-apical approach. For example, FIG. 11A is aschematic diagram illustrating a trans-septal approach for endovasculardelivery of an annuloplasty ring (not shown) to the mitral valve 1110 ofa heart 1100 according to one embodiment. For illustrative purposes, apartial cross-section of the heart 1100 is illustrated to show the rightatrium RA, right ventricle RV, left atrium LA, and left ventricle LV.For clarity, certain features (e.g., papillary muscles and chordaetendineae) are not shown. In the trans-septal approach shown in FIG.11A, the left atrium LA is approached by advancement of a catheter 1112through the inferior vena cava 1114, into the right atrium RA, acrossthe interatrial septum 1116, and into the left atrium LA. Theannuloplasty ring may then be delivered through the catheter 1112 intothe atrium and anchored to the annulus of the mitral valve 1110.

As shown in FIG. 11A, the catheter 1112 is delivered percutaneously intothe heart 1100. A guiding sheath (not shown) may be placed in thevasculature system of the patient and used to guide the catheter 1112and its distal end 1118 to a desired deployment site. In someembodiments, a guide wire (not shown) is used to gain access through thesuperior or inferior vena cava 1114, for example, through groin accessfor delivery through the inferior vena cava 1114. The guiding sheath maybe advanced over the guide wire and into the inferior vena cava 1114shown in FIG. 11A. The catheter 1112 may be passed through the rightatrium RA and towards the interatrial septum 1116. Once the distal end1118 of the catheter 1112 is positioned proximate to the interatrialseptum 1116, a needle or piercing member (not shown) is advanced throughthe catheter 1112 and used to puncture the fossa ovalis or other portionof the interatrial septum 1116. In some embodiments, the catheter 1112is dimensioned and sized to pass through the fossa ovalis withoutrequiring a puncturing device. That is, the catheter 1112 may passthrough the natural anatomical structure of the fossa ovalis into theleft atrium LA.

Similarly, any chamber (LV, RV, LA, RA) of the heart 1100 may beapproached through the inferior vena cava 1114. For example, the rightventricle RV may be approached through the inferior vena cava 1114, intothe right atrium RA, and through the tricuspid valve 1120. A variety ofother endovascular approaches may also be used.

FIG. 11B is a schematic diagram illustrating an example retrogradeapproach of an annuloplasty ring (not shown) to the mitral valve 1110 ofa heart 1100 according to another embodiment. In FIG. 11B, a femoralapproach is shown wherein the delivery catheter 1112 is advanced throughthe aorta 1122 and the aortic valve 1124. Typically, the catheter 1112is advanced through a sheath positioned within the femoral artery (notshown). Under fluoroscopy or other methods of guidance, the distal endof the catheter 1112 is guided within the left ventricle LV and turned(e.g., as shown with a “U-turn” 1126) within the left ventricle LV so asto pass through the leaflets of the mitral valve 1110 and into the leftatrium LA. After verification of the appropriate positioning of thecatheter 1112, a guide wire (not shown) may be inserted through thecatheter 1112 into the left atrium LA, which may then be used to guideone or more other catheters into the left atrium LA for delivering andanchoring the annuloplasty ring to the annulus of the mitral valve 1110.

FIG. 11C is a schematic diagram illustrating an example trans-apicalapproach of an annuloplasty ring (not shown) to the mitral valve 1110 ofa heart 1100 according to another embodiment. In this example, thecatheter 1112 is shown passing through the apex 1130 of the heart 1100,through the left ventricle LV, through the leaflets of the mitral valve1110, and into the left atrium. The annuloplasty ring, may be deliveredthrough the catheter 1112 into the left atrium LA and anchored to theannulus of the mitral valve 1110. In one embodiment, a needle or trocarmay be used to puncture through the apex 1130 to create a small openingthrough which a guide wire (not shown) can be inserted through the leftventricle LV into the left atrium LA. Then, the guide wire may be usedto guide successively larger and stiffer catheters so as to graduallyincrease the size of the opening in the apex 1130 of the heart 1100.

FIGS. 12A and 12B are schematic diagrams illustrating a delivery system1200 for implanting a segmented annuloplasty ring 1202 within a heartaccording to certain embodiments. FIG. 12A illustrates a perspectiveview of the delivery system 1200, including a distal end 1210 and aproximal end 1212. FIG. 12B illustrates an enlarged view of the proximalend 1212 shown in FIG. 12A. The distal end 1210 is discussed below inmore detail with respect to FIGS. 13A and 13B. The delivery system 1200includes an outer jacket delivery catheter 1214 having a proximal endattached to a hemostatic connector 1216.

The proximal end 1212 of the system 1200 includes a first torquecontroller 1218 for controlling a first suture 1219 used for snappingtogether the ends of the ring 1202, a second torque controller 1220 forcontrolling a second suture 1221 for deploying anchors (not shown) fromthe ring 1202, and a third torque controller 1222 for controlling a ringdeployment wire 1223 for orienting the ring 1202 within the heart andreleasing the ring 1202 from the delivery system 1200. The first suture1219 and/or the second suture 1221 may include a resilient materialcapable of providing a pulling force to elements within the ring 1202,as discussed below. Thus, the first suture 1219 and/or the second suture1221 may include, for example, Teflon, steel, or Nitinol. In oneembodiment, the ring deployment wire 1223 includes a superelastic shapememory material (e.g., Nitinol) for orienting the ring 1202, asdiscussed below. In some embodiments, the first suture 1219, the secondsuture 1221, and/or the ring deployment wire 1223 are Teflon-coated.

The first torque controller 1218, the second torque controller 1220, andthe third torque controller 1222 are connected to the hemostaticconnector 1216 through a four-port connector 1217. In one embodiment,the four-port connector 1217 comprises a luer port. The first torquecontroller 1218 is connected to the four-port connector 1217 through aspring tension luer 1225, a spring tension assembly 1226 and a springtension plunger 1228. The spring tension assembly 1226 includes aninternal spring (not shown) against which the plunger 1228 is biased toprovide a desired amount of tension to the first suture 1219 under thecontrol of the torque controller 1218, and to pull the first suture 1219to snap-lock the ends of the ring 1202 together. Similarly, the secondtorque controller 1220 is connected to the four-port connector 1217through a spring tension luer 1230, a spring tension assembly 1232 and aspring tension plunger 1234 to provide a desired amount of tension tothe second suture 1221 under the control of the second torque controller1220, and to pull the second suture 1221 to deploy the anchors. In oneembodiment, the first suture 1219 and/or the second suture 1221 mayinclude a notch (not shown) within or near the ring 1202 that isconfigured to break the respective suture 1219, 1221 by applyingadditional tension after the suture 1219, 1221 has performed itsrespective function (e.g., after the suture 1219 snaps the ends of thering 1202 together or after the suture 1221 deploys the anchors). Thethird torque controller 1222 is connected to the four-port connector1217 through an adapter 1224, such as a Touhy borst adapter.

FIGS. 13A, 13B, 13C, 13D, 13E, 13F, and 13G are schematic diagramsillustrating the front of the delivery system 1200 shown in FIG. 12Aaccording to certain embodiments. FIG. 13A illustrates a perspectiveview of the distal end 1210 of the delivery system 1200 up to thehemostatic connector 1216 of the proximal end. FIG. 13B illustrates anenlarged view of a portion of the distal end 1210 shown in FIG. 13A. Thedistal end 1210 includes a catheter shaft 1314 sized and configured topass through the outer jacket delivery catheter 1214, a ring shuttle1316 configured to be removably coupled to the pivot 108 of thesegmented annuloplasty ring 1202, a first deployment lumen 1320 throughwhich the first suture 1219 passes for snapping together the ends of thering closure lock 106, a second deployment lumen 1324 through which thesecond suture 1221 passes for deploying anchors (not shown) as discussedabove, and a third deployment lumen 1328 (FIG. 13C) through which thering deployment wire 1223 passes for orienting the ring 1202 within theheart and releasing the ring 1202 from the ring shuttle 1316.

FIGS. 13A and 13B show a first side of the distal end of the ringshuttle 1316 including the first deployment lumen 1320 (for snap lockingthe ring 1202) and the second deployment lumen 1324 (for deployinganchors), with the ring 1202 in the annular operable geometry having itsplane perpendicular to the longitudinal axis of the outer jacketdelivery catheter 1214 and the catheter shaft 1314 (e.g., as it would beoriented inside the heart and aligned with the valve annulus). In FIG.13C, a second side of the distal end of the ring shuttle 1316 is shownincluding the third deployment lumen 1328, with the ring 1202 in theelongate insertion geometry aligned with the longitudinal axis of thecatheter shaft 1314 and ready to be loaded into the outer jacketdelivery catheter shown in FIGS. 13A and 13B. In the configuration shownin FIG. 13C, the distal end of the ring deployment wire 1223 includes abend or hook 1332 as it passes through a hole in the pivot 108. The ringdeployment wire 1223 includes a superelastic shape memory material(e.g., Nitinol). As discussed below, bending the distal end of the ringdeployment wire 1223 into the hook 1332 shape spring loads the ring 1202within the outer jacket delivery catheter 1214 such that the ring 1202automatically rotates about the pivot 108 upon exiting the outer jacketdelivery catheter 1214.

FIG. 13D is a perspective view of the ring 1202 partially deployed fromthe distal end 1210 of the outer jacket delivery catheter 1214 in afirst deployment stage. In the first stage, the ring 1202 is stillsubstantially in the elongate insertion geometry. As shown in FIG. 13D,the first suture 1219 for snapping together the ends of the ring 1202passes through the male snap 112 of the ring closure lock 106.

FIG. 13E is a perspective view of the ring 1202 in a second stage ofpartial deployment from the outer jacket delivery catheter 1214. In thesecond stage, the portion of the ring 1202 that has exited the outerjacket delivery catheter 1214 has begun to transition (due to the shapememory materials used in the ring 1202) from the elongate insertiongeometry to the annular operable geometry. The ring 1202 may include awindow (not shown), e.g., laser cut through the outer hypotube alongwith the plurality of segments, that allows the first suture 1219 toexit the ring 1202.

FIG. 13F is a perspective view of the ring 1202 in a third stage ofdeployment in which the ring shuttle 1316 has substantially pushed thering 1202 out of the outer jacket delivery catheter 1214, but the planeof the ring 1202 is still aligned with (e.g., approximately parallel to)the longitudinal axis of the outer jacket delivery catheter 1214. Thisexample shows the configuration immediately before the ring deploymentwire 1223 cooperates with the pivot 108 to rotate the ring 1202 (seeFIG. 13G). At this stage, the hook 1332 shape in the superelastic ringdeployment wire 1223 is ready to unload (return to its straightconfiguration) as soon as the outer jacket delivery catheter 1214 nolonger prevents it from doing so.

FIG. 13G is a perspective view of the ring 1202 in a fourth stage ofdeployment in which the plane of the ring 1202 (in its annular operablegeometry) has been changed to be perpendicular to the longitudinal axisof the outer jacket delivery catheter 1214. As shown in FIG. 13G, thesuperelastic ring deployment wire 1223 has returned to its heat set(memorized) straight configuration. At this stage, the axis of the ring1202 is parallel to the plane of the heart valve annulus.

In further stages of deployment, the ring 1202 may be pressed against(e.g., using a balloon) the heart valve annulus before deploying theanchors (such as the curved anchors 104 shown in FIGS. 4A and 4B) bypulling the second suture 1221 toward the proximal end of the seconddeployment lumen 1324. As discussed above, certain anchor embodimentspropel themselves into the tissue of the heart valve annulus upon beingdeployed. In other embodiments, the anchors (such as the linear anchors710 shown in FIG. 7) may be deployed before pressing the ring 1202against the annulus. After the ring 1202 is anchored to the heart valveannulus (or after a balloon is holding the ring against the annulus),the ring deployment wire 1223 may be pulled from the hole in the pivot108 to release the ring 1202 from the ring shuttle 1316. The firstsuture 1219 and the second suture 1221 may also be cut and/or pulledfrom the ring 1202 before the catheters 1214, 1314 are removed from theheart.

FIGS. 14A, 14B, 14C, 14D, 14E, 14F, and 14G are schematic diagramsillustrating perspective, partially cross-section views of a heart 1100during the introduction and affixation of a segmented annuloplasty ring1400 to the annulus of the mitral valve 1110 according to certainembodiments. As shown, an outer jacket delivery catheter 1410 extendsfrom the left ventricle into the left atrium through the leaflets of themitral valve 1110. Thus, this illustrated embodiment may correspond to,for example, a trans-apical approach or a retrograde approach, asdiscussed above. Artisans will recognize from the disclosure herein,however, that similar principles as those illustrated may be used fortrans-septal approaches.

In FIG. 14A, the ring 1400 is in an elongate insertion geometry as it ispushed into the left atrium from a distal end of the catheter tube 1410.As discussed herein, a wire or suture 1412 used for snapping togetherthe ends of the ring 1400 is shown extending from a first end of thering 1410. FIG. 14B shows the ring 1400 partially deployed from thecatheter 1410. As discussed above, the superelastic shape memorycomponents of the ring 1400 cause the exposed end of the ring 1400 toreturn to its annular shape (D-shape) as it exits the catheter 1410.

FIG. 14C illustrates the ring 1400 fully deployed from the catheter 1410and transitioned from the elongate insertion geometry to the D-shapeoperable geometry. In this embodiment, the suture 1412 (shown in FIGS.14A and 14B) has been pulled so as to snap together the two ends of thering 1400. In other embodiments, however, the ends of the ring 1400 arenot snapped together until the ring 1400 has been anchored in place tothe valve annulus. See, for example, FIGS. 16B and 17.

For illustrative purposes, the plane of the ring 1400 in FIG. 14C isshown as parallel to the longitudinal axis of the catheter 1410 and aninner catheter shaft 1414. In this position, the plane of the ring 1400may be considered as perpendicular or substantially perpendicular to thevalve annulus. In other words, the plane of the ring 1400 as shown inFIG. 14C is substantially perpendicular to the direction of blood flowthrough the mitral valve 1110. As discussed above, the inner cathetershaft 1414 (e.g., via a ring shuttle) is coupled to and cooperates withthe 1416 to automatically rotate the ring 1400 as it exits the outercatheter 1410 so that the plane of the ring 1400 is parallel to theplane of the valve annulus, as shown in FIG. 14D. In other words, inFIG. 14D, the plane of the ring 1400 is substantially parallel to theblood flow through the mitral valve 1110. In FIG. 14D, a ring deploymentwire 1413 is shown, such as the ring deployment wire 1223 discussedabove. For clarity, the ring deployment wire 1413 is not shown in FIG.14C.

FIG. 14E illustrates the ring 1400 positioned on or next to the annulusof the valve 1110 with the anchors 1418 deployed. At this stage, in thisembodiment, the anchors 1418 are either not embedded within the annulustissue or are only partially inserted within the annulus tissue. Inother embodiments, however, the anchors 1418 self-propel themselves intothe annulus tissue when deployed. See, e.g., FIGS. 16B and 17. FIG. 14Eshows a balloon catheter 1420 extending through the distal end of theouter catheter 1410.

FIG. 14F shows a balloon 1422 of the balloon catheter 1420 in theprocess of being inflated and driving the anchors 1418 into the annulustissue around the valve 1110. FIG. 14G graphically illustrates theanchors 1418 embedded within the tissue 1424 (see FIG. 14G) of the valveannulus. In FIG. 14G, the catheters have been removed and the ring 1400is securely attached to the annulus of the mitral valve 1110 to restorethe valve opening to its approximate original size and operatingefficiency.

The balloon shown in FIG. 14F includes two sections and may beconsidered a “multi-chamber” balloon with two chambers. In otherembodiments, a balloon with a single chamber or a balloon with more thantwo chambers may be used to position the ring 1400 against the valveannulus and/or to drive the anchors 1418 into the surrounding tissue. Inthe embodiment shown in FIG. 14F, the inflated balloon 1422 may reduceor prevent the flow of blood through the mitral valve during at leastpart of the implantation procedure. In such embodiments, inflation ofthe balloon 1422 may last 20 seconds or less to prevent adverseconsequences of occluding the mitral valve. In other embodiments, bloodis allowed to flow through the mitral valve during the entire procedure.For example, FIG. 15 is a schematic diagram illustrating a perspective,partially cross-section view of the heart 1100 during the introductionand affixation of the segmented annuloplasty ring 1400 using anexpandable cage or basket 1500, instead of the balloon shown in FIG.14F, according to one embodiment. The basket 1500 includes a pluralityof flexible members 1510 that lay flat against a central rod 1514 duringinsertion of the basket 1500 through the catheter 1410 (shown in FIG.14A) and may be forced into an expanded configuration (shown in FIG. 15)when the central rod 1514 is pushed into an end cap 1512. In anotherembodiment, the plurality of flexible members 1510 comprise asuperelastic material so as to spring from the catheter 1410 into theexpanded configuration shown in FIG. 15.

FIG. 16A is a flowchart of a method 1600 for repairing a defective heartvalve according to one embodiment. The method 1600 includespercutaneously introducing 1610 a distal end of a first catheter into aleft atrium of a heart and inserting 1612 a segmented annuloplasty ring,attached to a second catheter, through the first catheter into the leftatrium. The ring includes a superelastic shape memory material thattransforms the ring from an elongate insertion geometry to an annularoperable geometry as the ring exits the distal end of the firstcatheter. The method 1600 further includes automatically rotating 1614the ring to change a plane of the ring from a first direction that isparallel to the second catheter to a second direction that is parallelto a plane of the mitral valve annulus, and pulling 1616 a first suture,connected to the ring through the second catheter, to couple the ends ofthe ring together. The method 1600 includes pulling 1618 a secondsuture, connected to the ring through the second catheter, to deploy aplurality of tissue anchors from the ring. Then, inserting 1620 anexpansion device through the first catheter into the left atrium andactivating the expansion device to press the ring against the valveannulus and drive the anchors into the surrounding tissue. The method1600 further includes detaching 1622 the ring from the second catheterand the first and second sutures, and remove the first and secondcatheters from the heart.

FIG. 16B is a flowchart of a method 1630 for repairing a defective heartvalve according to another embodiment. The method 1630 includespercutaneously introducing 1632 a distal end of a first catheter into aleft atrium of a heart, and inserting 1634 a segmented annuloplastyring, attached to a second catheter, through the first catheter into theleft atrium. The ring includes superelastic shape memory material thattransforms the ring from an elongate insertion geometry to an annularoperable geometry as the ring exits the distal end of the firstcatheter. The method 1630 further includes automatically rotating 1636the ring to change a plane of the ring from a first direction that isparallel to the second catheter to a second direction that is parallelto a plane of the mitral valve annulus, and inserting 1638 an expansiondevice through the first catheter into the left atrium and activatingthe expansion device to press the ring against the valve annulus.Pressing the ring against the annulus at this stage allows thesubsequent deployment of the anchors to propel the anchors into theannulus tissue. Thus, the method 1630 further includes pulling 1640 afirst suture, connected to the ring through the second catheter, todeploy a plurality of tissue anchors from the ring. Each of theplurality of anchors includes a superelastic shape memory material thatpropels the superelastic anchors into the tissue of the valve annulus.The method 1630 further includes pulling 1642 a second suture, connectedto the ring through the second catheter, to couple the ends of the ringtogether and cinch the valve annulus to a desired size. The method 1630also includes detaching 1644 the ring from the second catheter and thefirst and second sutures, and removing the first and second cathetersfrom the heart.

FIG. 17 is a schematic diagram illustrating a perspective, partiallycross-section view of the heart 1100 during the introduction andaffixation of a segmented annuloplasty ring 1700 according to anotherembodiment. In this embodiment, a balloon 1710 is inflated beforeanchors 1712 are deployed. The balloon 1710 in this embodiment is“donut-shaped” (i.e., it includes a central opening) to allow blood toflow through the valve during the entire procedure. With the ring 1700pressed against the valve annulus, the anchors 1712 are deployed. Asdiscussed above, the anchors 1712 comprises a superelastic shape memorymaterial that assists in driving the anchors 1712 into valve annulustissue 1713. For illustrative purposes, the anchors 1712 in FIG. 17 areshown with dashed lines to represent being embedded within the tissue1713.

Additional Example Embodiments

FIG. 18 is a schematic diagram of a percutaneous transcatheterannuloplasty ring 1800 in an annular operable geometry according to oneembodiment. The annuloplasty ring 1800 can be affixed to heart tissue inand/or around a defective heart valve to treat (e.g., reduce)regurgitation of blood through leaflets of the heart valve. For example,the annuloplasty ring 1800, in the operable geometry, may be affixed tothe annulus of the heart valve and used to cinch the annulus to draw theopening smaller or into an improved shape that reduces regurgitation ofblood back through the valve. FIG. 19A is a schematic diagramillustrating the percutaneous transcatheter annuloplasty ring 1800 ofFIG. 18 in an insertion geometry according to one embodiment. FIG. 19Bis a schematic diagram of the percutaneous transcatheter annuloplastyring 1800 transitioning from the insertion geometry shown in FIG. 19A tothe operable geometry shown in FIG. 18 according to one embodiment.

Referring generally and collectively to FIGS. 18, 19A, and 19B, theannuloplasty ring 1800 may include a plurality of segments 1802 flexiblycoupled together. Flexible coupling of the plurality of segments 1802may be accomplished with a plurality of hinges 1804. The annuloplastyring 1800 may further include a securement mechanism 1806, such as a pinor clasp, to couple together ends of the annuloplasty ring 1800 to formthe annular operable geometry. In the displayed example, the hinges 1804comprise pin joints and the securement mechanisms 1806 comprise pins.The plurality of segments 1802 and plurality of hinges 1804 allow theannuloplasty ring 1800 to unfold or open from a curved and/or annularoperable geometry into an elongate flexible insertion geometry asillustrated in FIG. 19A.

The plurality of segments 1802 may be arranged in a serial or lineararrangement (e.g., a chain of interconnected segments 1802) having afirst end 1920 and a second end 1922. The plurality of segments 1802 maybe formed of a biocompatible material, or a combination of multiplebiocompatible materials, including but not limited to Nitinol andplastic. The plurality of segments 1802 may be formed to enhanceflexibility when in the insertion geometry and to enhance rigidity whenin the operable geometry. The plurality of segments 1802 and/or theannuloplasty ring 1800 may include shape memory material to bias orotherwise aid in transitioning the annuloplasty ring 1800 to the curvedoperable geometry.

The plurality of hinges 1804 couple together the plurality of segments1802. Each segment 1802 may be coupled to an adjoining segment via acorresponding hinge 1804. The hinges 1804 may be configured tofacilitate folding or closing the annuloplasty ring 1800 to transitionbetween the insertion geometry and the operable geometry, as shown inFIG. 19B. In certain embodiments, each of the plurality of hinges 1804is configured to lock into a secured state when the associated(adjoining) segments 1802 are in the operable geometry. Thus, a hinge1804 may allow adjoining segments 1802 to freely rotate within a rangeof motion to provide flexibility, and the hinge 1804 may lock to limitrotation of the adjoining segments 1802 and provide rigidity whenrotation of the adjoining segments exceeds the range of motion and theadjoining segments 1802 are in their respective positions of theoperable geometry. In another embodiment, the plurality of hinges 1804may include a flexible piece of material. For example, a hinge 1804 maybe formed of a portion of the same material as the plurality of segments1802. In still another embodiment, the plurality of hinges 1804 areintegrated with, or formed integrally with, the plurality of segments1802. For example, the plurality of segments 1802 and the plurality ofhinges 1804 may be cut from a single piece of material, such as aNitinol tube.

A ring closure lock 1910 secures the first end 1920 to the second end1922 to form the circular or annular shape of the operable geometry. Thering closure lock 1910 of the illustrated embodiment is a snap-lock inwhich a ball 1912 (male snap) on the second end 1922 is received andsnaps into a mating socket 1914 (female snap) on the first end 1920 whenthe ball 1912 is urged toward and into the socket 1914 with sufficientforce. In another embodiment, the ring closure lock 1910 may include aclasp or other locking mechanism. In another embodiment, the ringclosure lock 1910 may be any locking mechanism that allows a firstcomponent to easily slide past a second component in a first directionbut that prevents the first component from sliding back in the oppositedirection past the second component. In another embodiment, the ringclosure lock 1910 may include magnets configured to attract the ends1920, 1922 together.

A ring closing mechanism 1916, such as a suture or wire, may be mountedacross the ends 1920, 1922 to facilitate bringing the ends 1920, 1922 ofthe annular ring 1800 together and engagement of the ring closure lock1910. In the illustrated embodiment, the ring closing mechanism 1916 maybe a suture. The suture 1916 may be configured and arranged through aneyelet 1932 or hook (or around a knob) on the second end 1922. The endsof the suture 1916 may also be threaded through an eyelet 1930 on thefirst end 1920 and back through the catheter out of the patient's body.The ends of the suture 1916 may be pulled or otherwise manipulated by apractitioner from external to the patient's body to draw the second end1922 toward the first end 1920. In this manner, the ball 1912 can beforced into the socket 1914 to secure the ends 1920, 1922 together andthe annuloplasty ring 1800 in the operable geometry. Once the ring lockclosure is secured (e.g., locked) in place, one end of the suture 1916can be pulled to pull the suture 1916 through the eyelets 1930, 1932 andout of the patient's body.

The operable geometry of the annuloplasty ring 1800 may be curved toalign or substantially conform to the sized and/or shape of an annulusof a properly functioning heart valve of the type to be repaired. In theillustrated embodiment, the operable geometry is circular or annular, asshown in FIG. 18. The operable geometry may be designed and configuredto provide structure and rigidity to properly cinch and/or support adefective valve to correct regurgitation of blood back through thevalve. In one embodiment, the operable geometry provides rigidity in atleast a direction transverse to a plane of the curved shape of theoperable geometry. The plane of the curved shape may be defined by alongest diameter of the curved shape and a second diameter of the curvedshape that is perpendicular to the first diameter. Stated differently,the operable geometry may provide rigidity along (e.g., in a directionparallel to) a circumferential axis of the curved shape. Thecircumferential axis may be defined through the center of the opening ofthe ring and extending parallel to a direction of a flow of bloodthrough the annuloplasty ring 1800 when it is properly implanted in theheart valve. In FIG. 18, the circumferential axis may be defined by aline extending from the center of the annuloplasty ring 1800 directlyout of and perpendicular to the page. The annuloplasty ring 1800 in theoperable geometry may, in one embodiment, be rigid radially relative tothe circumferential axis. In another embodiment, the operable geometrymay be flexible radially relative to the circumferential axis.

The insertion geometry, as shown in FIG. 19A, allows the annuloplastyring 1800 to be flexible and in an elongate and somewhat linear state tobe inserted into a catheter tube. An annuloplasty ring, such asannuloplasty ring 1800, disposed in a catheter tube can be delivered andaffixed to the defective heart valve via a percutaneous transcatheterdelivery method. More specifically, a tip of a catheter tube of adelivery apparatus can be percutaneously inserted into a vascularstructure of a vasculature of a body of a patient. The catheter tube ofthe delivery apparatus can be guided through the vasculature of thepatient into a chamber of a heart of the patient and adjacent to thedefective heart valve to be repaired. For example, delivery of theannuloplasty ring to the mitral valve may be accomplished via retrogradeapproach from the femoral artery, or an antegrade approach via atrans-septal entry. As another example, delivery of the annuloplastyring into the tricuspid valve may be accomplished via an approach fromthe inferior or superior vena cava.

The annuloplasty ring 1800 may be configured to enable cinching of theheart tissue proximate the valve and/or cinching of the annulus of thevalve, after affixation of the annuloplasty ring 1800 (e.g.,postoperatively), to reduce regurgitation of blood back through leafletsof the valve.

FIG. 20A is a schematic diagram illustrating a percutaneoustranscatheter annuloplasty ring 2000 according to another embodiment.The annuloplasty ring 2000 is shown in FIG. 20A in an annular operablegeometry with anchors 2008 in an introduction configuration. FIG. 20B isa schematic diagram illustrating an enlarged side view of theannuloplasty 2000 ring of FIG. 20A. The annuloplasty ring 2000 mayinclude an inner support structure 2040 and an outer shell 2042. In FIG.20A, the inner support structure 2040 is shown in phantom lines as beinghidden by the outer shell 2042. The inner support structure 2040 may beformed of a plurality of segments 2002, as shown in FIG. 1D anddiscussed more fully in other embodiments disclosed herein. The outershell 2042 may be formed of a thin super-elastic material, such asNitinol. The anchors 2008 may extend from and/or be integrated with theouter shell 2042. Superelastic shape memory material in the plurality ofsegments 2002 of the inner support structure 2040 and/or the outer shell2042 enable the annuloplasty ring 2000 to transition between aninsertion geometry and an operable geometry.

The anchors 2008, when in an introduction configuration, may be foldedor wrapped to lie in close proximity to the outer shell 2042, as shownin FIG. 20B, so as to not protrude away from the surface of theannuloplasty ring 2000. The anchors 2008 may include a prong 2052 and abarb 2054 at an end of the prong. The barb 2054 may facilitatesecurement of the anchor 2008 in tissue.

FIG. 20C is a schematic diagram of the annuloplasty ring 2000 of FIG.20A with the anchors 2008 in an affixation configuration protruding awayfrom the annuloplasty ring 2000. An integrated diaphragm 2062 may beintegrated with the outer shell 2042 and/or the inner support structure2040. Inflation of the integrated diaphragm 2062 unfurls the anchors2008 to expose the barbs 2054 for affixation (implantation) of theannuloplasty ring 2000 into a heart valve annulus. In anotherembodiment, rather than including an integrated diaphragm 2062, aballoon catheter (not shown) may be used to deploy the anchors 2008.

Those having skill in the art will understand from the disclosure hereinthat many changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention. The scope of the present invention should, therefore, bedetermined only by the following claims.

1. An annuloplasty ring for transcatheter heart valve repair, theannuloplasty ring comprising: an outer hollow member comprising aplurality of segments, wherein adjacent segments cooperate with oneanother to change the outer hollow member from an elongate insertiongeometry to an annular operable geometry; and an internal anchor memberlocated at least partially within the outer hollow member, the internalanchor member comprising a plurality of anchors configured to attach theannuloplasty ring to tissue of a heart valve annulus, the internalanchor member configured to move the plurality of anchors with respectto a plurality of windows in the outer hollow member to selectivelydeploy the plurality of anchors through the respective windows.
 2. Theannuloplasty ring of claim 1, wherein the plurality of hollow segmentsallow the outer hollow member to be flexible in a first plane so as tobe transitionable between the elongate insertion geometry and theannular operable geometry, and wherein the plurality of hollow segmentsin the annular insertion geometry are at least semi-rigid in a secondplane that is perpendicular to the first plane.
 3. The annuloplasty ringof claim 1, wherein the outer hollow member comprises a first end and asecond end, and wherein the first end is configured to couple to thesecond end in the annular operable geometry.
 4. The annuloplasty ring ofclaim 3, further comprising: a female snap-lock connector attached tothe first end of the outer hollow member; and a male snap-lock connectorattached to the second end of the outer hollow member.
 5. Theannuloplasty ring of claim 4, further comprising a suture or wireincluding a distal end configured to draw the male snap lock connectorinto the female snap lock connector by applying tension to a proximalend of the suture or wire.
 6. The annuloplasty ring of claim 1, furthercomprising a pivot configured to removably couple the annuloplasty ringto a catheter, the pivot further configured to automatically rotate aplane of the annuloplasty ring upon exiting a catheter within a heartchamber.
 7. The annuloplasty ring of claim 1, wherein the outer hollowmember comprises a superelastic shape memory material configured toautomatically transition from the elongate insertion geometry to theannular operable geometry upon exiting a catheter within a heartchamber.
 8. The annuloplasty ring of claim 7, wherein the outer hollowmember comprises a shape memory tube cut in a pattern to form theplurality of segments in a continuous series of connected segments. 9.The annuloplasty ring of claim 8, wherein in the elongate insertiongeometry, the cut shape memory tube include gaps partially separatingadjacent connected segments, and wherein in the annular operablegeometry, one or more of the gaps close.
 10. The annuloplasty ring ofclaim 1, wherein the internal anchor member comprises a superelasticshape memory material configured to automatically transition at least aportion of the internal anchor member from the elongate insertiongeometry to the annular operable geometry upon exiting a catheter withina heart chamber.
 11. The annuloplasty ring of claim 10, wherein theinternal anchor member comprises a first shape memory ribbon having theplurality of anchors cut therein, wherein the plurality of anchors areconfigured to automatically transition to a curved shape upon exitingthe respective windows in the outer hollow member, and wherein thetransition to the curved shape self-propels the plurality of anchorsinto the tissue of the heart valve annulus.
 12. The annuloplasty ring ofclaim 11, further comprising a second shape memory ribbon within theouter hollow member, the second shape memory ribbon configured to reducefriction between the first shape memory ribbon and the outer hollowmember to assist in deploying the anchors.
 13. The annuloplasty ring ofclaim 12, wherein the second shape memory ribbon is superelastic and isconfigured to automatically transition from the elongate insertiongeometry to the annular operable geometry upon exiting the catheterwithin the heart chamber.
 14. The annuloplasty ring of claim 12, whereinthe second shape memory ribbon comprises a selectively adjustable memberconfigured to be activated postoperatively by application of externalenergy to change the shape of the annuloplasty ring.
 15. Theannuloplasty ring of claim 10, wherein the internal anchor membercomprises a shape memory tube cut to form a plurality of prongs betweentubular portions of the tube, wherein the prongs are transition tolinear configurations of respective anchors upon exiting the respectivewindows in the outer hollow member.
 16. The annuloplasty ring of claim15, further comprising a selectively adjustable member passing throughthe tubular portions of the shape memory tube, the selectivelyadjustable member configured to be activated postoperatively byapplication of external energy to change the shape of the annuloplastyring.
 17. The annuloplasty ring of claim 15, further comprising one ormore barbs attached to each of the plurality of prongs.
 18. Theannuloplasty ring of claim 1, further comprising a suture or wireincluding a distal end removably coupled to the internal anchor member,the suture or wire configured to slide the internal anchor member withinthe outer hollow member, by applying tension to a proximal end of thesuture or wire, so as to deploy the plurality of anchors from therespective windows.
 19. The annuloplasty ring of claim 1, wherein theannular operable geometry comprises a D-shape corresponding to ananatomical geometry of a human mitral valve annulus, wherein theannuloplasty ring in the annular operable geometry comprises a firstdimension corresponding to an anterior-posterior dimension of the mitralvalve annulus and a second dimension corresponding to acommissure-commissure dimension of the mitral valve annulus, and whereina ratio of a distance of the first dimension to a distance of the seconddimension is in a range between about 0.60 and about 0.70.
 20. A methodfor percutaneous transcatheter repair of a mitral valve in a heart, themethod comprising: percutaneously introducing a distal end of a firstcatheter into a left atrium of the heart; inserting a segmentedannuloplasty ring, attached to a second catheter, through the firstcatheter into the left atrium, the ring including a superelastic shapememory material that transforms the ring from an elongate insertiongeometry to an annular operable geometry as the ring exits the distalend of the first catheter; automatically rotating the ring to change aplane of the ring from a first direction that is parallel to the secondcatheter to a second direction that is parallel to a plane of a mitralvalve annulus; pulling a first suture, connected to the ring through thesecond catheter, to couple the ends of the ring together; pulling asecond suture, connected to the ring through the second catheter, todeploy a plurality of tissue anchors from the ring; and inserting anexpansion device through the first catheter into the left atrium andactivating the expansion device to press the ring against the mitralvalve annulus so as to drive the anchors into the surrounding tissue.21. The method of claim 20, further comprising: detaching the ring fromthe second catheter and the first and second sutures; and removing thefirst and second catheters from the heart.
 22. The method of claim 20,wherein percutaneously introducing the distal end of the first catheterinto the left atrium of the heart comprises a trans-septal approachthrough the inferior vena cava, right atrium, and interatrial septuminto the left atrium.
 23. The method of claim 20, wherein percutaneouslyintroducing the distal end of the first catheter into the left atrium ofthe heart comprises a retrograde approach through the aorta, aorticvalve, left ventricle, and mitral valve into the left atrium.
 24. Themethod of claim 20, wherein percutaneously introducing the distal end ofthe first catheter into the left atrium of the heart comprises atrans-apical approach through the apex of the heart, left ventricle, andmitral valve into the left atrium.
 25. A method for percutaneoustranscatheter repair of a mitral valve in a heart, the methodcomprising: percutaneously introducing a distal end of a first catheterinto a left atrium of the heart; inserting a segmented annuloplastyring, attached to a second catheter, through the first catheter into theleft atrium, the ring including a superelastic shape memory materialthat transforms the ring from an elongate insertion geometry to anannular operable geometry as the ring exits the distal end of the firstcatheter; automatically rotating the ring to change a plane of the ringfrom a first direction that is parallel to the second catheter to asecond direction that is parallel to a plane of a mitral valve annulus;inserting an expansion device through the first catheter into the leftatrium and activating the expansion device to press the ring against themitral valve annulus; pulling a first suture, connected to the ringthrough the second catheter, to deploy a plurality of tissue anchorsfrom the ring as it is pressed against the mitral valve annulus, whereineach of the plurality of anchors includes a superelastic shape memorymaterial that self-propels the superelastic anchors into the tissue ofthe mitral valve annulus; and pulling a second suture, connected to thering through the second catheter, to couple the ends of the ringtogether and cinch the mitral valve annulus to a desired size.
 26. Themethod of claim 25, further comprising: detaching the ring from thesecond catheter and the first and second sutures; and removing the firstand second catheters from the heart.
 27. The method of claim 26, whereinpercutaneously introducing the distal end of the first catheter into theleft atrium of the heart comprises a trans-septal approach through theinferior vena cava, right atrium, and interatrial septum into the leftatrium.
 28. The method of claim 26, wherein percutaneously introducingthe distal end of the first catheter into the left atrium of the heartcomprises a retrograde approach through the aorta, aortic valve, leftventricle, and mitral valve into the left atrium.
 29. The method ofclaim 26, wherein percutaneously introducing the distal end of the firstcatheter into the left atrium of the heart comprises a trans-apicalapproach through the apex of the heart, left ventricle, and mitral valveinto the left atrium.
 30. A delivery system for percutaneoustranscatheter delivery of an annuloplasty ring to repair a heart valveof a body of a patient, the delivery apparatus comprising: an outerjacket delivery catheter; a catheter shaft sized and configured to passthrough the outer jacket delivery catheter; a ring shuttle attached to adistal end of the catheter shaft, the ring shuttle configured to beremovably coupled to a segmented annuloplasty ring; a first deploymentlumen sized and configured to pass through the outer jacket deliverycatheter, the first deployment lumen configured to provide a pathway fora first suture for coupling together first and second ends of the ring;a second deployment lumen sized and configured to pass through the outerjacket delivery catheter, the second deployment lumen configured toprovide a pathway for a second suture for deploying anchors from thering; and a third deployment lumen sized and configured to pass throughthe outer jacket delivery catheter, the third deployment lumenconfigured to provide a pathway for a ring deployment wire forautomatically orienting the ring within the heart and selectivelyreleasing the ring from the ring shuttle.
 31. The delivery system ofclaim 30, further comprising: a hemostatic connector coupled to aproximal end of the outer jacket delivery catheter; a first torquecontroller coupled to the hemostatic connector for selectivelycontrolling the first suture for coupling together first and second endsof the ring; a second torque controller coupled to the hemostaticconnector for selectively controlling the second suture for deployingthe anchors from the ring; and a third torque controller coupled to thehemostatic connector for selectively controlling the ring deploymentwire for releasing the ring from the ring shuttle.
 32. The deliverysystem of claim 30, wherein the ring deployment wire comprises asuperelastic shape memory material biased as the ring shuttle passesthrough the outer jacket delivery catheter for automatically orientingthe ring within the heart upon pushing the ring from the outer jacketdelivery catheter.